Legislation

Proposals for Legislation Governing Assisted Human Reproduction

On 3 May 2001 the federal Minister of Health referred draft legislation on assisted human reproduction to the House of Commons Standing Committee on Health, with a request that the Committee review the legislation and provide its views on options for a possible regulatory body that would govern implementation of the legislation. The Committee has been asked to report by 31 January 2002.

The draft legislation consists of a preamble, definitions, a list of prohibited activities, a list of controlled activities, procedures for administering the act, privacy and access to information considerations, provisions for inspection and enforcement, and miscellaneous items. It was accompanied by several background documents: Proposals for Legislation Governing Assisted Human Reproduction: An Overview, Guide to the Proposals for Legislation Governing Assisted Human Reproduction, Frequently Asked Questions, The International Scene, A Selection of Relevant Website Addresses and Documents Relating to Assisted Human Reproduction and Glossary of Terms. All these documents are available on Health Canada’s web site: www.hc-sc.gc.ca/english/reproduction/.

In May and June the Committee heard testimony on the draft legislation from the Minister, Health Canada officials, several scientists and clinicians working on assisted reproduction, several ethicists, Dr. Patricia Baird of the Royal Commission on New Reproductive Technologies and several representatives of religious organizations. Proceedings of these hearings can be viewed on the Parliament of Canada web site at: www.parl.gc.ca/InfoCom/CommitteeMinute.asp?Language=E&Parliament=8 &Joint=0&CommitteeID=147. The Committee will resume public hearings in September 2001.

For further information contact Rhonda Ferderber, Director, Health Policy and Communications Branch, Special Projects Division, Brooke Claxton Building, Tunney’s Pasture, Room 937D, P.L. 0909D, Ottawa, ON K1A 0K9, tel (613) 957-8994, fax (613) 941-9093, email: rhonda_ferderber@hc-sc.gc.ca.

Regulations Amending the Food and Drug Act Regulations (1024 – Clinical Trials)

On 7 June 2001 regulations dealing with the sale and importation of drugs for use in human clinical trials were published in the Canada Gazette Part II. They were accompanied by a regulatory impact analysis statement. The regulations come into effect on 1 September 2001.

The regulations are part of a framework for drug approval that includes the following features:

• A 30-day default review period for applications to sell a drug for the conduct of human drug clinical trials in Canada in Phases I to III of development;
• Clear and transparent requirements for application, information, amendments, notification, labelling, record keeping and adverse drug reaction reporting;
• Introduction of an inspection system against internationally accepted good clinical practice principles and good manufacturing practices; and
• Clear authority to refuse an application, suspend or cancel the sale of drugs for use in clinical trials in Canada where they do not meet the updated regulatory requirements.

The regulations define the mandate and membership of Research Ethics Boards (REBs) and require REB approval for conduct of a clinical trial at each trial site. The regulatory impact analysis statement notes the following implications of the regulations for REBs:

• Benefits: The amendment will provide federal recognition of the important service provided by REBs. It will improve consistency relating to the roles and responsibilities of these Canadian Boards by providing a standard for generally accepted principles of good clinical practice. The policy evaluation conducted clearly identified the need to have a formal accreditation system for REBs. An accreditation system would promote compliance with good clinical practices. The regulations require that sponsors obtain REB approval prior to conducting trials. This may facilitate new funding mechanisms for these Boards.
• Costs: REBs that review and approve the conduct of human clinical trials in Canada are not currently subject to federal regulations or accreditation. They follow one or a number of federal or provincial guidelines. Some REBs follow foreign guidelines. The only Canadian clinical drug trials that must be reviewed by REBs are those involving minors and incompetent adults conducted in Quebec. Section 21 of the Quebec Civil Code requires an ethical review by a designated REB for all types of research involving these populations. There has been some concern expressed by those REBs who do not have the expertise and funding to ensure that drug trials can be conducted according to generally accepted principles of good clinical practice. Those REBs who are not able to undertake this responsibility with respect to the conduct of drug trials must concentrate their efforts in other fields. This regulation may increase the operational costs of REBs.

The regulatory impact analysis statement notes that there are slight differences between the Regulations and the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans with regard to membership requirements for REBs.

The Regulations can be viewed on the Canada Gazette web site at: http://canada.gc.ca/gazette/hompar2-2_e.html. For further information contact Karen Reynolds, Policy Division, Bureau of Policy and Coordination, Therapeutics Products Directorate, Health Products and Goods Branch, Health Canada, 2^nd Floor, Tower B, 1600 Scott St., Address Locator: 3102C5, Ottawa, ON K1A 1B6, tel (613) 941-6225, fax (613) 941-6458, email: karen_reynolds@hc-sc.gc.ca.